KYORIN Pharmaceutical Co.,Ltd. · TSE:4569
KYORIN Pharmaceutical Co.,Ltd — H1 FY2021 Earnings Presentation
36 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, Nov 9, 2021
Slide 1: Interim Term Financial Results Ended September 2021
Interim Term Financial Results Ended September 2021 November 9 , 2021 KYORIN Holdings, Inc. President Yutaka Ogihara
Slide 2: Agenda
➢ Outline of Consolidated Financial Results • Trends of mainstay products, Generic products ➢ Consolidated Financial Forecast ➢ Status of R&D Pipeline ➢ Initiative toward realization of the long-term vision “HOPE100” 1
Slide 3: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results 2
Slide 4: Segment Sales and Breakdown of Gain and Loss
Segment Sales and Breakdown of Gain and Loss Change Change (forecast) （Units: ¥billion） Sep/20 Sep/21 Change Announced on (%) May 11,2021 Sales 47.7 49.1 n/a n/a +1.8 New ethical drugs, etc. 32.9 33.3 n/a n/a +1.4 （Japan） New ethical drugs（Overseas） 0.5 0.3 n/a n/a －0.2 Generic drugs 14.4 15.5 n/a n
Slide 5: Highlights of Business Performance: Net sales
Highlights of Business Performance:①Net sales （Units: ¥billion） 47.7 49.1 50 New ethical drugs, etc.(Japan) 40 14.4 15.5 Increased ・New drugs (Beova,Desalex,Lasvic) grew ・Sales of long-listed products (Pentasa etc.) 0.5 0.3 30 New ethical drugs （Overseas） Decreased 20 32.9 33.3 Generic drugs Increas
Slide 6: Highlights of Business Performance: Operating Income
Highlights of Business Performance : ②Operating Income （Units：¥billion） 50.0 Net sales increased Cost of Cost of sales ratio sales ratio Cost of sales ratio increased 40.0 48.0 54.4 ＜Reasons of increase＞ % % ⚫ Impact of NHI drug price revision Cost of (Kyorin Pharmaceutical : 6％ range) Cost of sales
Slide 7: Highlights of Business Performance: Change (forecast)
Highlights of Business Performance: ③Change (forecast) Change (forecast) （Units：¥billion） Sep/20 Sep/21 Change Change(%) Announced on May 11,2021 Net Sales 47.7 49.1 n/a n/a +1.8 New ethical drugs, etc.(Japan) 32.9 33.3 n/a n/a +1.4 New ethical drugs (Overseas) 0.5 0.3 n/a n/a －0.2 Generic drugs 14.
Slide 8: Main Product Sales Update
Main Product Sales Update （Units：¥billion） Change (forecast) Sep/20 Sep/21 Change Change(%) Announced on May 11,2021 Flutiform (Combination drug for asthma treatment) 6.4 6.3 －0.1 －1.2 －0.3 Desalex (Antiallergic Agent) 1.8 2.6 ＋0.8 ＋42.9 －0.2 Beova (β3 adrenergic receptor agonist overactive bladder
Slide 9: Trends of mainstay products and Generic drugs
Trends of mainstay products and Generic drugs 8
Slide 10: Main Product Flutiform (Anti-asthmatic)
■Main Product Flutiform（Anti-asthmatic） sales 2nd half （Units：bln） （Unit：％） （Units：bln） 1st half ICS/LABA market Flutiform Share of 16.0 (Apr-Sep) Flutiform 14.6 13.9 60 20 14.0 13.1 13.3 15.8 15.2 12.0 11.9 15 12.6 7.9 40 11.9 10.0 7.0 6.9 7.6 11.0 6.5 8.0 60.8 10 55.2 56.7 51.1 6.0 45.7 20 4.0 5 6
Slide 11: Main Product Desalex (Antiallergic Agent)
■Main Product Desalex（Antiallergic Agent） Sales （Units：bln） Antihistamine market （Unit：％） （Units：bln） Desalex 2nd half 1st half 80 8 (Apr-Sep) Share of Desalex 8 7.2 5.9 60 5.2 6 6 5.7 4.1 4.9 Supply suspended: about 10 months 4.6 40 4 74.9 4 3.7 66.1 68.4 3.9 58.7 55.9 0.9 2.6 4.0 20 1.4 2 2 2.8 2.
Slide 12: Main Product Beova/Uritos (OAB)
■Main Product Beova/Uritos（OAB） OAB market Sales 2nd half （Units：bln） Share of （Unit：％） （Units：bln） Beova 1st half (Apr-Sep) Beova 10 50 9.2 10 8.6 8.9 8 40 8 7.3 4.3 30 6 6 44.3 46.6 48.5 47.3 3.5 44.8 4.3 20 4 4 1.8 10 2 3.7 2 3.8 4.3 4.1 0.7 (forecast) 0 0 0.7 0 0.6 Mar/18 Mar/19 Mar/20 Mar/21 Ma
Slide 13: Main Product Lasvic (Antibacterial Agent)
■Main Product Lasvic（New quinolone synthetic antibacterial agent) Sales 2nd half ◆ （Units：bln） Oral antimicrobial market （Unit：％） （Units：bln） Share of Lasvic 1st half 60 (Apr-Sep) Lasvic 5 3 2.8 4 40 2 3 2.0 60.2 50.4 48.7 2.7 2 20 1 0.9 1.4 1 1.1 0.7 0.8 30.7 31 .3 1.1 0.2 (forecast) 0 0 0 Mar/20 M
Slide 14: Status of Generic Drugs
■Status of Generic Drugs Sales 2nd half （Units：bln） Generic Drugs Sales 1st half 35.0 33.1 32.2 31.0 30.0 29.3 27.7 ◼Status in first half 2021 25.0 17.6 16.8 17.8 Action for an authorized generic drug(AG) 15.7 20.0 14.7 ●Montelukast AG, Mometasone AG, Imidafenacin AG maintain the market share of mor
Slide 15: Consolidated Financial Forecast
Consolidated Financial Forecast 14
Slide 16: Consolidated Financial Forecast in FY2021
Consolidated Financial Forecast in FY2021 FY2021 Y/Y FY2020 （Units：¥billion） （forecast） Change Change(%) Net 102.9 102.6 n/a n/a sales New ethical drugs, etc.(Japan) 69.7 68.6 n/a n/a New ethical drugs (Overseas) 1.0 0.8 n/a n/a Generic drugs 32.2 33.1 n/a n/a Cost of Sales 51.3 ー ー ー SG&A 45.8 ー ー
Slide 17: Forecast of Mainstay Products Sales
Forecast of Mainstay Products Sales FY2020 FY2021 YoY （Units：¥billion） (Actual) (Forecast) Change Change(%) Flutiform (Combination drug for asthma treatment) 13.3 13.9 ＋0.6 ＋4.8 Desalex (Antiallergic Agent) 5.7 7.2 ＋1.5 ＋27.2 Beova(Kyorin) (β3 adrenergic receptor agonist overactive bladder therapeut
Slide 18: Shareholder Returns
Shareholder Returns Capital Policy ・While maintaining the sound financial base, we aim to improve the capital efficiency through growth investment and returns to shareholders ・We will maintain stable dividends taking DOE (Dividend on Equity ratio) into account Revision of Dividend Level In considera
Slide 19: Application for New Market Segment Prime Market on TSE
Application for New Market Segment “Prime Market” on the Tokyo Stock Exchange KYORIN Holdings,Inc. (Head Office: Chiyoda-ku Tokyo Japan, hereafter “KYORIN”) received on July 9, 2021 the results of the initial assessment of its compliance with the listing standards of the new market segments to be in
Slide 20: Status of R&D Pipeline
_Kyorin 2) Status of R&D Pipeline
Slide 21: Drug R&D Pipeline: Progress (Plan in FY2020)
Drug R&D Pipeline: Progress Plan in FY2020 Approval/ development code PhⅠ PhⅡ PhⅢ application Launch KRP-R120 Respiratory Gefapixant MSD (Feb) citrate Infections KRP-A218 (Apr) KRP-116D Launched (Apr) Urology AKP-009 ASKA in progress ※ Gefapixant citrate: Concluded Distribution Agreement in Japan wi
Slide 22: Drug R&D Pipeline: Progress in FY2021
Drug R&D Pipeline: Progress Progress in FY2021 Approval/ development code PhⅠ PhⅡ PhⅢ application Launch KRP-R120 Completed Respiratory Gefapixant MSD (Feb) citrate Infections KRP-A218 (Apr) KRP-116D Launched (Apr) Urology ※ AKP-009 ASKA interrupted ※ASKA started an additional PhⅠ study to confirm t
Slide 23: Initiative toward realization of the long-term vision HOPE 100
Initiative toward realization of the long-term vision “HOPE 100” 22
Slide 24: Overview of Medium-Term Business Plan HOPE 100-Stage 3-
Overview of Medium-Term Business Plan “HOPE 100-Stage 3-” Statement : Realize growth trend by pursuing Kyorin’s originality ・Shift to business based on the proposal of solutions and accelerate the growth of new drug groups. ・ Enhance pipeline to support medium-term growth Business Strategy ・ Strengt
Slide 25: Solution Provision Activities in Infection Domain
Shift to business based on the proposal of solutions Solution Provision Activities in Infection Domain Response to changing environment ”Lasvic tablets 75mg ” “Lasvic IV Drip Infusion Kit 150mg” （MR activities/Medical care provision system） ・Contribute to respiratory and ENT infection along with tab
Slide 26: Effort in diagnosis business
Shift to business based on the proposal of solutions Effort in diagnosis business “Genetic Analyzer GeneSoC® mini Launch: End of Nov GeneSoC® mini GeneSoC® Aspect Diameter 10.5cm/Height 15.5cm Width 62cm/Depth 29cm//Height 15.4cm Notification General medical device Laboratory equipment Principle RT-
Slide 27: Enhance pipeline to support medium-term growth
Enhance pipeline to support medium-term growth Interstitial cystitis “Zymso Intravesical Solution 50%” Launched : Apr 2021 ▶As a new treatment, Zymso contributes to patient treatment and better QOL Indication : Improvement of symptoms of interstitial cystitis (Hunner type) (chronic pelvic pain, pres
Slide 28: Pulmonary sarcoidosis treatment KRP-R120 trial design
Enhance pipeline to support medium-term growth Pulmonary sarcoidosis treatment “KRP-R120” aTyr社 ATYR1923 Ph 1b/2a Study Trial Design Design • Randomized (2:1), double-blind, placebo-controlled, multiple ascending dose • 24 week study: 6monthly IV dose of ATYR1923 being tested at 1.0, 3.0, 5.0 mg/kg
Slide 29: Pulmonary sarcoidosis treatment KRP-R120 results
Enhance pipeline to support medium-term growth Pulmonary sarcoidosis treatment “KRP-R120” Primary Endpoint ⚫ The trial met its endpoint : Safe and well-tolerated Secondary Endpoint ⚫ 58% overall steroid reduction from baseline and 22% relative reduction in steroid utilization post taper in the 5.0mg
Slide 30: Treatment agent for BPH AKP-009
Enhance pipeline to support medium-term growth Treatment agent for BPH “AKP-009” Development Outline ⚫ PhⅡa study（Randomized, double-blind, parallel-group comparative study with placebo as a control） ⚫ Target treatment ： Benign Prostatic Hyperplasia patients ⚫ Number : About 100 ⚫ Frequency of admin
Slide 31: Strengthen drug discovery capability
Strengthen drug discovery capability to realize the creation of innovative new drugs Cooperation Watarase Research Center ActivX(USA) Open innovation Open innovation Academia, Venture Pharmaceutical companies in Japan and overseas Selection and Concentration Drug discovery Kyoto University Priority
Slide 32: KRP-A218 a Treatment for Rhinovirus infection
Strengthen drug discovery capability to realize the creation of innovative new drugs “KPR-A218” a Treatment for Rhinovirus infection Development background Discovered from Kinase research by Watarase Drug Discovery Center and ActivX in the United States Development status Started PhⅠ in Apr 2021 in
Slide 33: Discovery for Lung Diseases course at Kyoto University
Strengthen drug discovery capability to realize the creation of innovative new drugs “Discovery for Lung Diseases” course at Graduate School of Kyoto University (Phase 2) Purpose of Joint Research A joint research course "Discovery for Lung Disease" was established in 2017 at the Graduate School of
Slide 34: Accelerate growth of new drug groups
Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Accelerate growth of new drug groups ◼ Maximize the spread of Flutiform and Desalex ◼ Establish Lasvic’s position as a quinolone for respiratory and otolaryngological infections ◼ Accelerate growth of B
Slide 35: Disclaimer
Disclaimer This material contains performance forecasts, goals and plans, and other forward- looking statements related to the Group. These statements are based on the judgment of the Group’s assumptions and outlooks based on the information and forecasts available at the time of preparation of this
Slide 36: Kyorin @)
Kyorin @) Kyorin ©)